Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu’s Arteritis

Brief Title

Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu's Arteritis

Official Title

Comparison of the Efficacy of Mycophenolate Mofetil Combined With Methotrexate and Cyclophosphamide for the Treatment of Takayasu's Arteritis

Brief Summary

      Takayasu's arteritis(TAK) is a rare systemic vasculitis which can cause ischemia or
      inflammation of the involved organs and increase the overall mortality rate.The traditional
      treatment of TAK is primarily empirical. The most commonly used drugs for treating active TAK
      are glucocorticosteroids(GC) and immunosuppressants. However, the genital toxicity of CYC has
      limited its long term use. In a pilot study carried out by the principal investigator of this
      study has shown that mycophenolate mofetil(MMF) combined with MTX is effective and with few
      adverse effects. The purpose of this prospective open-label study is to compare the efficacy
      and safety of GC+MMF+MTX with GC+CYC followed by GC+AZA for the treatment of active TAK. 150
      patients with active TAK will be recruited and randomized in a 2:1 ratio to GC+MMF+MTX group
      and C+CYC and AZA group. Patients were followed for 52 weeks for efficacy and safety
      assessment.
    

Detailed Description

      Takayasu's arteritis(TAK) is a rare systemic vasculitis which mainly involves aorta and its
      major branches. However,it is more prevalent in countries and areas along the silk road.Young
      women at child-bearing age is the most prevalent population.It can cause ischemia or
      inflammation of the involved organs and increase the overall mortality rate.Although it may
      be lethal in some patients,it is not well studied due to the rareness of the disease.The
      traditional treatment of TAK is primarily empirical. The most commonly used drugs for
      treating active TAK are glucocorticosteroids(GC) and immunosuppressants including
      cyclophosphamide(CYC), methotrexate(MTX) and azathioprine(AZA) etc. However,no of these drugs
      have been well studied. In addition, the genital toxicity of CYC, the first line medication
      for active TAK, has become the major limitation for its long term use for a chronic disease
      like TAK. Therefore, new immunosuppressants with less toxicity,especially with much less
      genital toxicity and low malignancy risk is essentially necessary. In a pilot study carried
      out by the principal investigator of this study has shown that mycophenolate mofetil(MMF)
      combined with MTX is effective and with few adverse effects. The purpose of this prospective
      open-label study is to compare the efficacy and safety of GC+MMF+MTX with GC+CYC followed by
      GC+AZA for the treatment of active TAK. 150 patients with active TAK will be recruited and
      randomized in a 2:1 ratio to GC+MMF+MTX group and C+CYC and AZA group. Patients were followed
      for 52 weeks to assess the efficacy and safety.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Proportion of patients with complete remission

Secondary Outcome

 Proportion of patients with partial remission

Condition

Takayasu Arteritis

Intervention

MMF

Study Arms / Comparison Groups

 MMF+MTX+Glucocorticoids

Description:  Patients were treated with Glucocorticoids combined with mycphenolate mofetil(MMF) as well as methotrexate(MTX) treatment for 52 weeks and were followed for 52 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

150

Start Date

March 16, 2017

Completion Date

December 1, 2018

Primary Completion Date

October 1, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Patients older than 18 years-old either sex

          2. Patients with signed informed consent

          3. Fulfill the 1990 ACR Classification Criteria for TAK

          4. Patients with active disease according to GACTA criteria

        Exclusion Criteria:

          1. Prior adverse events when treated with MTX that resulted in dose reduction or
             discontinuation;

          2. Prior treatment with MMF but failed response to MMF;

          3. Prior treatment with CYC but failed response to CYC;

          4. Renal dysfunction, defined as the estimated GFR <80% or serum creatinine level higher
             than 1.5 times of upper normal limit;

          5. Severe liver function damage defined by serum ALT or AST higher than 2 times of the
             upper normal limits;

          6. Uncontrolled diabetes melitus;

          7. Uncontrolled heart failure at baseline;

          8. Active infection including tuberculosis , hepatitis B virus, hepatitis C virus, HIV or
             bacterial or fungal infection;

          9. Active upper GI bleeding in the past 3 months.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Xinping Tian, MD, 86-10-69158795, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT03096275

Organization ID

PUMCHCSTAR-006

Responsible Party

Principal Investigator

Study Sponsor

Chinese SLE Treatment And Research Group

Collaborators

 Peking Union Medical College Hospital

Study Sponsor

Xinping Tian, MD, Principal Investigator, Peking Union Medical College Hospital

Verification Date

April 2017